Non-small Cell Lung CancerRICT-LUNGNCT03416972
Detecting Radiation-Induced Cardiac Toxicity After Non-Small Cell Lung Cancer Radiotherapy
An observational study of Non-small Cell Lung Cancer and Radiation Toxicity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Lung cancer is the most common cause of cancer death in Canada. For approximately 30% of patients that present with locally-advanced non-small cell lung cancer (NSCLC), the standard treatment is curative-intent concurrent chemoradiotherapy. Outcomes remain poor, with 5-year survival of only 20%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer, Radiation Toxicity
- What is being tested?
- Standard platinum-based chemoradiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jan 2018to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ultimately, the sample size was based upon practical considerations and that 20 NSCLC patients (10 Stage I/II and 10 Stage III) could be accrued relatively easily from new patient clinics, while sufficiently providing enough evidence to validate the imaging techniques to be used as a non-invasive measure for future clinical trials aimed at reducing or mitigating radiation-induced cardiac toxicity.
Who may be able to join
- Age 18 or older
- Ability to provide informed consent
- Histologically confirmed carcinoma of the lung
- Stage I-III NSCLC
- Stage I-II patients to receive 54 Gy in 3 fractions, 55 Gy in 5 fractions, or 60 Gy in 8 fractions (treated every other day)
- Stage III patient to receive concurrent chemoradiation ( 60 Gy in 30 daily fractions)
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- No prior RT to the thorax
- ECOG performance status 0-1 within one month of accrual
- Expected lifespan at least 1 year
- Negative pregnancy test within one month of accrual if woman is premenopausal
- Patient presented at multidisciplinary tumor board or quality-assurance rounds
- Satisfactory pulmonary function tests as determined by the treating radiation oncologist (ie. FEV1 >= 0.8 for Stage III NSCLC and no threshold for Stage I/II).
Who cannot join
- Patients receiving Prescription RT dose to anything other than LRCP standards for Stage I-III NSCLC.
- Prior history of atrial fibrillation
- Previous coronary bypass surgery
- Patients with severe reversible airways obstruction
- Patients with acute coronary syndrome (STEMI/non-STEMI and unstable angina)
- AV block without pacemaker
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- Patients who are renal insufficient (eGFR <40)
- Patients with asthma
- Allergy to iodinated contrast for scans (study subject will be eligible for non-contrast scans)
- Use of metformin-containing products less than 24 hours prior to CT contrast administration
- Other contraindications to iodinated contrast media as determined by the research team.
- Allergy to gadolinium for scans using contrast; will be eligible for non-contrast scans.
- Other contraindications to gadolinium contrast media as determined by the research team.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Lawson Health Research Institute
London, Ontario, N6C 2R5
James Sinfield, 519-685-8500 ext. 53349, james.sinfield@lhsc.on.ca
Albert Gratton, 519-685-8500 ext. 53233, albert.gratton@lhsc.on.ca
About this study
Official title: Identification of Acute Radiation-induced Cardiac Toxicity After Non-small Cell Lung Cancer Radiotherapy With Advanced Multi-modality Imaging (RICT-LUNG)
Lung cancer is the most common cause of cancer death in Canada. For approximately 30% of patients that present with locally-advanced non-small cell lung cancer (NSCLC), the standard treatment is curative-intent concurrent chemoradiotherapy. Outcomes remain poor, with 5-year survival of only 20%. Despite the long-held belief that higher radiation doses lead to improved overall survival (OS), the landmark randomized trial (RTOG 0617) showed the opposite. The investigators hypothesize that the inferior survival observed may be due to unexpected heart toxicity as secondary analysis revealed that the heart dose was a strong predictor of inferior OS. Up to now, change in heart function is typically detected histologically, requiring autopsy tissue. Therefore, a non-invasive marker of early heart damage is required. Hybrid PET-MRI has become available in Canada only recently. The ability to simultaneously perform metabolic imaging with functional and tissue imaging allows for novel assessment of heart toxicity. The primary objective is to examine the utility of hybrid PET-MRI and DCE-CT to assess acute changes in heart function and to measure inflammation before, and six weeks after NSCLC radiotherapy. A pilot of 20 patients with Stage I-III NSCLC will be enrolled. The findings of this study will aid in the design of new studies to reassess dose escalation for locally advanced NSCLC while limiting the risk of heart toxicity. FDG PET will be used to simultaneously assess both cardiac inflammation and tumour response. Quantitative DCE-CT will also be used to measure ventilation and perfusion changes in the normal lung and tumour after radiotherapy, providing image data that can comprehensively assess both tumour response and potential toxicity in both the heart and lungs. Such information is crucial in understanding the disease and its response to treatment. This data will also aid in the design of radiation techniques that spare the heart in other patients with any thoracic malignancies, including breast cancer, lymphoma, and esophageal cancer.
Read the detailed description
The investigators propose a longitudinal imaging pilot study composed of 20 Stage I-III NSCLC patients before, and six weeks after standard radiotherapy using a hybrid 3T-PET/MRI system (Biograph mMR, Siemens Healthcare) and a GE Revolution 256-slice CT scanner. The imaging protocol is designed to detect acute changes in myocardial perfusion, inflammation, edema, left ventricular ejection fraction, normal lung and tumour perfusion, and tumour metabolism. During each imaging session, patients will receive an 18F-FDG PET scan to image macrophage-related inflammation and tumour metabolism, MRI to identify edema, mature fibrosis or scar, and Dynamic contrast enhanced CT (DCE-CT) imaging to image perfusion and (LVEF). All images will be fused and rendered with radiation treatment planning dose distributions. Parameters such as Standard Uptake Value (SUV) will be used to compare PET scans, while heart volume and presence of Gadolinium enhancement will be used to compare MRI scans. Blood flow, blood volume, and permeability will be used to compare CT scans. Blood tests including Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin at each timepoint will also be performed to detect cardiac inflammation. Comparisons between Stage I/II and Stage III patients will allow us to determine whether our metrics for heart changes is radiation related. Relative differences from the six-week time point to baseline will be correlated with the radiation dose distribution to attempt to define a dose-response relationship between radiation dose and cardiac toxicity.
- Conditions
- Non-small Cell Lung Cancer, Radiation Toxicity
- Being tested
- Standard platinum-based chemoradiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard platinum-based chemoradiotherapyRadiation
Stage III patients: Standard platinum-based chemotherapy, total radiation dose 60 Gy in 30 fractions. Stage I/II patients: Standard radiotherapy, total radiation dose of 54 Gy in 3 fractions (peripheral), 55 Gy in 5 fractions (near chest wall), or 60 Gy in 8 fractions (central).
| Study group | Role | What they receive |
|---|---|---|
| Stage I-III NSCLC patients | Stage I/II NSCLC patients receiving standard stereotactic body radiation therapy and Stage III patients receiving Standard platinum-based chemoradiotherapy will receive PET/MRI, DCE-CT, ECG/EKG, and bloodwork before and six weeks post treatment. Receives: Radiation: Standard platinum-based chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Imaging Biomarkers of acute cardiac inflammation
FDG-PET imaging to detect increase in cardiac inflammation compared to baseline with corresponding blood markers (Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin levels in blood (inflammation)).
Measured: 6 weeks
Detection of Imaging Biomarkers of acute cardiac perfusion changes
DCE-CT imaging to detect changes in acute cardiac perfusion changes compared to baseline.
Measured: 6 weeks
Detection of Imaging Biomarkers of acute changes in Left-ventricular ejection fraction (LVEF)
Contrast-enhanced CT imaging to detect acute changes in LVEF compared to baseline.
Measured: 6 weeks
Detection of cardiac fibrosis
Gadolinium Enhanced MR imaging to detect cardiac fibrosis compared to baseline
Measured: 6 weeks
Secondary outcomes (4)
Tumour Response (metabolism)
FDG-PET imaging to detect tumour metabolism changes compared to baseline.
Measured: 6 weeks
Tumour Response (perfusion)
DCE-CT imaging to detect changes in tumour perfusion compared to baseline
Measured: 6 weeks
Acute Changes in Lung Ventilation
4D-CT imaging to detect changes in lung ventilation compared to baseline
Measured: 6 weeks
Acute Changes in Lung Perfusion
DCE-CT imaging to detect changes in lung perfusion compared to baseline
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start11 Jan 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Stewart Gaede, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416972
- Sponsor's protocol ID
- R-17-360
- Acronym
- RICT-LUNG
- Status last verified
- Jan 2018
- First submitted
- 22 Dec 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Acute Radiation-induced Cardiac Toxicity After Non-small Cell Lung Cancer Radiotherapy With Advanced Multi-modality Imaging (RICT-LUNG)
- ClinicalTrials.gov ID
- NCT03416972
- Acronym / sponsor ID
- RICT-LUNG / R-17-360
- Conditions
- Non-small Cell Lung Cancer, Radiation Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the most common cause of cancer death in Canada. For approximately 30% of patients that present with locally-advanced non-small cell lung cancer (NSCLC), the standard treatment is curative-intent concurrent chemoradiotherapy. Outcomes remain poor, with 5-year survival of only 20%. Despite the long-held belief that higher radiation doses lead to improved overall survival (OS), the landmark randomized trial (RTOG 0617) showed the opposite. The investigators hypothesize that the inferior survival observed may be due to unexpected heart toxicity as secondary analysis revealed that the heart dose was a strong predictor of inferior OS. Up to now, change in heart function is typically detected histologically, requiring autopsy tissue. Therefore, a non-invasive marker of early heart damage is required. Hybrid PET-MRI has become available in Canada only recently. The ability to simultaneously perform metabolic imaging with functional and tissue imaging allows for novel assessment of heart toxicity. The primary objective is to examine the utility of hybrid PET-MRI and DCE-CT to assess acute changes in heart function and to measure inflammation before, and six weeks after NSCLC radiotherapy. A pilot of 20 patients with Stage I-III NSCLC will be enrolled. The findings of this study will aid in the design of new studies to reassess dose escalation for locally advanced NSCLC while limiting the risk of heart toxicity. FDG PET will be used to simultaneously assess both cardiac inflammation and tumour response. Quantitative DCE-CT will also be used to measure ventilation and perfusion changes in the normal lung and tumour after radiotherapy, providing image data that can comprehensively assess both tumour response and potential toxicity in both the heart and lungs. Such information is crucial in understanding the disease and its response to treatment. This data will also aid in the design of radiation techniques that spare the heart in other patients with any thoracic malignancies, including breast cancer, lymphoma, and esophageal cancer.
Detailed description
The investigators propose a longitudinal imaging pilot study composed of 20 Stage I-III NSCLC patients before, and six weeks after standard radiotherapy using a hybrid 3T-PET/MRI system (Biograph mMR, Siemens Healthcare) and a GE Revolution 256-slice CT scanner. The imaging protocol is designed to detect acute changes in myocardial perfusion, inflammation, edema, left ventricular ejection fraction, normal lung and tumour perfusion, and tumour metabolism. During each imaging session, patients will receive an 18F-FDG PET scan to image macrophage-related inflammation and tumour metabolism, MRI to identify edema, mature fibrosis or scar, and Dynamic contrast enhanced CT (DCE-CT) imaging to image perfusion and (LVEF). All images will be fused and rendered with radiation treatment planning dose distributions. Parameters such as Standard Uptake Value (SUV) will be used to compare PET scans, while heart volume and presence of Gadolinium enhancement will be used to compare MRI scans. Blood flow, blood volume, and permeability will be used to compare CT scans. Blood tests including Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin at each timepoint will also be performed to detect cardiac inflammation. Comparisons between Stage I/II and Stage III patients will allow us to determine whether our metrics for heart changes is radiation related. Relative differences from the six-week time point to baseline will be correlated with the radiation dose distribution to attempt to define a dose-response relationship between radiation dose and cardiac toxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage I-III NSCLC patients | – | Radiation: Standard platinum-based chemoradiotherapyStage I/II NSCLC patients receiving standard stereotactic body radiation therapy and Stage III patients receiving Standard platinum-based chemoradiotherapy will receive PET/MRI, DCE-CT, ECG/EKG, and bloodwork before and six weeks post treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ultimately, the sample size was based upon practical considerations and that 20 NSCLC patients (10 Stage I/II and 10 Stage III) could be accrued relatively easily from new patient clinics, while sufficiently providing enough evidence to validate the imaging techniques to be used as a non-invasive measure for future clinical trials aimed at reducing or mitigating radiation-induced cardiac toxicity.
Key inclusion criteria (12 listed)
- Age 18 or older
- Ability to provide informed consent
- Histologically confirmed carcinoma of the lung
- Stage I-III NSCLC
- Stage I-II patients to receive 54 Gy in 3 fractions, 55 Gy in 5 fractions, or 60 Gy in 8 fractions (treated every other day)
Key exclusion criteria (13 listed)
- Patients receiving Prescription RT dose to anything other than LRCP standards for Stage I-III NSCLC.
- Prior history of atrial fibrillation
- Previous coronary bypass surgery
- Patients with severe reversible airways obstruction
- Patients with acute coronary syndrome (STEMI/non-STEMI and unstable angina)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard platinum-based chemoradiotherapyStage III patients: Standard platinum-based chemotherapy, total radiation dose 60 Gy in 30 fractions. Stage I/II patients: Standard radiotherapy, total radiation dose of 54 Gy in 3 fractions (peripheral), 55 Gy in 5 fractions (near chest wall), or 60 Gy in 8 fractions (central). | Radiation | Stage I-III NSCLC patients |
Primary outcome
Detection of Imaging Biomarkers of acute cardiac inflammation
Time frame: 6 weeks
FDG-PET imaging to detect increase in cardiac inflammation compared to baseline with corresponding blood markers (Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin levels in blood (inflammation)).
Detection of Imaging Biomarkers of acute cardiac perfusion changes
Time frame: 6 weeks
DCE-CT imaging to detect changes in acute cardiac perfusion changes compared to baseline.
Detection of Imaging Biomarkers of acute changes in Left-ventricular ejection fraction (LVEF)
Time frame: 6 weeks
Contrast-enhanced CT imaging to detect acute changes in LVEF compared to baseline.
Detection of cardiac fibrosis
Time frame: 6 weeks
Gadolinium Enhanced MR imaging to detect cardiac fibrosis compared to baseline
4 secondary outcomes
Tumour Response (metabolism)
Time frame: 6 weeks
Tumour Response (perfusion)
Time frame: 6 weeks
Acute Changes in Lung Ventilation
Time frame: 6 weeks
Acute Changes in Lung Perfusion
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stewart Gaede, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Radiation Toxicity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stewart Gaede, PhD (519-685-8600 ext. 53144, stewart.gaede@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Imaging Biomarkers of acute cardiac inflammation (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.